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NAHAM Patient Access Regulatory Issues Management
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NAHAM Patient Access Regulatory Issues Management Page

As part of NAHAM’s Strategic Plan, NAHAM’s Policy Development & Government Relations Committee is monitoring the following key regulatory issues identified as those affecting the day-to-day operations of Patient Access. This is not an exhaustive list and NAHAM members are welcome to suggest additional issues.

Last updated: March 11, 2020


The NAHAM PD&GR Committee: Regulatory Updates (Posted: March 11,2020)

The NAHAM PD&GR Committee would like to inform the NAHAM members of the following regulatory updates. The Office of Management and Budget renewed and updated the IMM (CMS-10065) and DND (CMS-10066). The IMM revision now has a new CMS Form number: CMS-10065 (formerly CMS-R-193). Hospitals must use the updated IMM and DND by April 1, 2020.


Form Instructions for the Important Message from Medicare  (IM) CMS-10065 

Form Instructions for the Detailed Notice of Discharge  (DND) CMS-10066 


Please also note that the updated MSP Form Questionaire includes two additional questions. 

See IMM and MSP Sections below for more information. 


Feel free to contact with any questions. 


Appropriate Use Criteria (AUC) for Advanced Imaging Services

The Centers for Medicare and Medicaid Services (CMS) will soon implement new imaging requirements through an Appropriate Use Criteria for Advanced Imaging Services to reduce inappropriate or incorrect imaging orders. CMS will begin to implement these criteria in 2020 as a voluntary compliance year and will require full compliance beginning in 2021. These criteria may significantly affect the imaging-servicing process at healthcare facilities that order or deliver imaging services, thereby affecting patient access professionals.

Check out the NAHAM Blog for more information. 

For more information, see Appropriate Use Criteria Program 

Questions regarding this program may be submitted to the CMS Imaging AUC resource box:


Important Message from Medicare (IMM)

The Centers for Medicare and Medicaid Services (CMS) requires that all Medicare inpatients (outpatients not applicable) receive written information in person about their hospital discharge appeal rights. A Detailed Notice of Discharge (DND) explains the reason for the discharge and is given only if a beneficiary requests an appeal. Please note that observation patients that convert to inpatients would need to have this form completed. Hospitals are strongly encouraged to begin using the new Important Message from Medicare (IM) and Detailed Notice of Discharge (DND) as soon as possible, but no later than May 1, 2020. New 6/12/2020


 A-0117 (Rev. 75, Issued: 12-02-11, Effective: 12-02-11, Implementation: 12-02-11) §482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible



CMS requires hospitals to follow the protocol below to deliver this IMM to Medicare beneficiaries:

  • The IMM is a standard notice that must delivered to all Medicare inpatients within two days of admission and no more than two calendar days before discharge.
  • The IMM form cannot be altered from its original form and must have the control number appear on the notice.
  • The time-frame for delivering this form is located in the Conditions of Participation (CoPs) 482.13(a)(1).
  • The beneficiary (patient or representative) signs and dates the notice to acknowledge receipt.  

The registration department is often responsible for initially delivering the form.  It is important to remember that CMS requires 100-percent compliance for delivery, therefore, ensuring compliance through internal audit processes to monitor the timeliness of delivering both the IMM admission and discharge forms is recommended.

See NAHAM CMS Survey Toolkit for additional information (III-8. Regulations and Guidance: Important Message from Medicare (IMM)).

Questions regarding IMM and DND can be submitted at  New 6/12/2020


Find the relevant regulatory text for Conditions of Participation: Patient's Rights at 42 Code of Federal Regulations 482.13.


Medical Outpatient Observation Notice (MOON)

Hospitals and CAHs are required to provide a Medical Outpatient Observation Notice (MOON) to Medicare beneficiaries (including Medicare Advantage health plan enrollees) informing them that they are outpatients receiving observation services and are not inpatients of a hospital or critical access hospital (CAH).


The MOON is mandated by the Federal Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act), passed on August 6, 2015. This law amended Section 1866(a)(1) of the Social Security Act by adding new subparagraph (Y) that requires hospitals and CAHs to provide written notification and an oral explanation of such notification to individuals receiving observation services as outpatients for more than 24 hours at the hospitals or CAHs.

Full instructions in Section 400, of Chapter 30 of the CMS Claims Processing Manual.


To download the MOON and instructions, please click on the appropriate link below in "Downloads." Frequently asked questions ("MOON FAQs") are also available under "Downloads" below.


Send MOON questions to:


Useful downloads:

See also NAHAM CMS Survey Toolkit for additional information (III-2. Regulations and Guidance: Medical Outpatient Observation Notice (MOON)).

Advance Beneficiary Notice of Noncoverage (ABN) Updated July 2020

The Advance Beneficiary Notice of Noncoverage (ABN), Form CMS-R-131, is issued by providers (including independent laboratories, home health agencies, and hospices), physicians, practitioners, and suppliers to Original Medicare (fee for service - FFS) beneficiaries in situations where Medicare payment is expected to be denied. The ABN is issued to transfer potential financial liability to the Medicare beneficiary in certain instances.  If a notice is not obtained, the beneficiary may not be held financially liable if Medicare denies payment. 


Examples of situations in which ABNs may be executed:   

 - When services are not indicated for the diagnosis or treatment of the beneficiary

 - When not considered safe and/or effective

 - When more than the number of services Medicare allows is given in a specific period

 - When considered experimental or investigational


July 2020 Update 

In July 2020, CMS issued a renewed ABN Form with a new expiration date of June 30, 2023. All CMS providers must use this new form by August 31, 2020. Download the renewed ABN Form


Guidelines for issuing the ABN are published in the Medicare Claims Processing Manual, Chapter 30, Section 50.

In general, see
Fee For Service Advance Beneficiary Notice.

- Forms are updated periodically – instructions and tutorial provided

Medicare Advance Written Notices of Noncoverage (Medicare Learning Network, September 2017) – Current booklet for provider and beneficiary

HIPAA Privacy & Release of Information with Business Associates Updated July 2020

The HIPAA Privacy Rule establishes national standards to protect individuals’ medical records and other personal health information and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically. The Rule requires appropriate safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization. The Rule also gives patients rights over their health information, including rights to examine and obtain a copy of their health records, and to request corrections.

In general, see The HIPAA Privacy Rule.

See also Summary of the HIPAA Privacy Rule.

See also HIPAA Basics for Providers: Privacy, Security, and Breach Notification Rules (Medicare Learning Network, September 2018).

See NAHAM CMS Survey Toolkit for additional information (III-1. Regulations and Guidance: HIPAA Notice of Privacy Practice).

See also NAHAM Joint Commission Survey Toolkit (VI. Other Resources and Links).

Emergency Medical Treatment and Labor Act (EMTALA) Updated July 2020

In 1986, Congress enacted the Emergency Medical Treatment & Labor Act (EMTALA) to ensure public access to emergency services regardless of ability to pay. Section 1867 of the Social Security Act imposes specific obligations on Medicare-participating hospitals that offer emergency services to provide a medical screening examination (MSE) when a request is made for examination or treatment for an emergency medical condition (EMC), including active labor, regardless of an individual's ability to pay. Hospitals are then required to provide stabilizing treatment for patients with EMCs. If a hospital is unable to stabilize a patient within its capability, or if the patient requests, an appropriate transfer should be implemented.

In general, see Emergency Medical Treatment & Labor Act (EMTALA).


See QSO-20-15 Hospital-CAH-EMTALA REVISED for requirements and implications related to Coronavirus Disease 2019 (COVID-19).

See NAHAM CMS Survey Toolkit for additional information (III-9. Regulations and Guidance: Emergency Medical Treatment & Labor Act (EMTALA)).

Medicare Secondary Payer (MSP)

Medicare Secondary Payer (MSP) is the term generally used when the Medicare program does not have primary payment responsibility - that is, when another entity has the responsibility for paying before Medicare.


In general, see Medicare Secondary Payer.

See NAHAM CMS Survey Toolkit for additional information (III-7. Regulations and Guidance: Medicare Secondary Payer (MSP)).


Find the relevant regulatory text for Exclusions from Medicare and Limitations on Medicare Payment at 42 Code of Federal Regulations Part 482.


Please also note that the updated MSP Form Questionaire includes two additional questions. 


501r Pricing Transparency

The Affordable Care Act (ACA), enacted March 23, 2010, added new requirements that hospital organizations must satisfy in order to be described in section 501(c)(3), as well as new reporting and excise taxes. Many of these provisions became effective as of the date of enactment. The Community Health Needs Assessment (CHNA) requirements, discussed below, became effective for tax years beginning after March 23, 2012.

In general, see New requirements for 501(c)(3) Hospitals Under the Affordable Care Act.

See also Price Transparency in Health Care (report from the HFMA Price Transparency Task Force (2014).


See also HFMA Improving Pricing Transparency.

Advanced Directives

At the time of admission, patients must be given a written summary of their healthcare decision-making rights (form developed by the state) and the facility's policies with respect to recognizing advance directives.


The Federal Patient Self Determination Acti (enacted in 1990) addresses the rights of health (including mental health) care users to stipulate in advance how they would like to be treated by health care providers when they are incapacitated. These wishes can be articulated by consumers in a specific document (an advance directive) or by appointing someone as a health care agent to speak for them.


An advance directive is defined as a written instruction, such as a living will or durable power of attorney for health care, recognized under state law (whether statutory or as recognized by the courts of the State), relating to the provision of health care when the individual is incapacitated. The federal law does not require individuals to complete any form of advance directive and it specifically forbids requiring an advance directive as a requisite for treatment.


Find the relevant regulatory text for Notice of Privacy Practices of Protected Health Information at 45 Code of Federal Regulations 164.520.

CMS Documentation of Administrative Gender


The Office of the National Coordinator for Health Information Technology (ONC) issued a final rule for its 2015 Edition for health IT certification criteria.  The new criteria require Certified Electronic Health Record Technology (CEHRT) to include fields to capture the patient's "Administrative Gender" as either male (M), female (F) or unknown (UNK).  Specifically, beginning with the April 2016 annual release, eCQMs are required to use the HL7 V3 value set for AdministrativeGender (not AdministrativeSex) when specifying birth sex. 


The value set intent is to capture the biologic phenotypic sex that would be captured on the patient’s initial birth certificate. If the data is missing, it is not possible to determine the patient sex, or the patient’s birth certificate sex is undetermined, then one should use the nullFlavor “UNK” as is described above in race and ethnicity.


The CMS QRDA Implementation Guide provides additional guidance on how to use null values to describe race, ethnicity, and administrative sex data when the response is declined by the patient or is unknown.


See Identifying the Transgender Population in the Medicare Program (Transgender Health, Volume 1.1 2016), available as an Open Access article. 


See also NAHAM's Best Practices for Improved Patient Data Collection. 



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